Skip to main content

MINI REVIEW article

Front. Transplant.
Sec. Cell and Stem Cell Transplantation
Volume 4 - 2025 | doi: 10.3389/frtra.2025.1491568
This article is part of the Research Topic The Future of Islet Transplantation: Beyond the BLA View all articles

Demise of Cadaveric Islet Transplantation in the USA: Quo Vadis, One Year After BLA Approval and 24 Years After the Edmonton Breakthrough?

Provisionally accepted
PIOTR WITKOWSKI PIOTR WITKOWSKI 1*Nicole Wojcik Nicole Wojcik 1Nathan Appelbaum Nathan Appelbaum 1John J Fung John J Fung 1Rolf Barth Rolf Barth 1Camillo Ricordi Camillo Ricordi 2
  • 1 The University of Chicago, Chicago, United States
  • 2 University of Miami, Coral Gables, Florida, United States

The final, formatted version of the article will be published soon.

    Over one year after the BLA approval for CellTrans, cadaveric islet transplantation remains in demise in the United States. While the therapy is unavailable to Americans, it is already a standard of care procedure in other countries, including Europe, Canada, and Australia. This article discusses the challenges stemming from an outdated regulatory framework in the U.S. concerning cadaveric islet transplantation. It also presents advocacy efforts by the transplant community for appropriate regulatory adjustments and discusses future perspectives.Twenty-four years ago, the Edmonton protocol enabled the clinical success of cadaveric islet transplantation (1). Following this breakthrough, the transplant community endeavored to implement the same procedure in the U.S. Although regulatory frameworks for cells, tissues,

    Keywords: Type 1 diabetes mellitus, Regulatory update, islet, Transplantation, Food and Drug Administration

    Received: 05 Sep 2024; Accepted: 10 Jan 2025.

    Copyright: Âİ 2025 WITKOWSKI, Wojcik, Appelbaum, Fung, Barth and Ricordi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: PIOTR WITKOWSKI, The University of Chicago, Chicago, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.